Abstract

High-profile cases of infectious diseases transmitted from organ donors to transplant recipients, such as the transmission of human immunodeficiency virus, have driven policy globally. Many nations have or are developing regulations requiring reporting and investigation of such disease transmissions as part of broader biovigilance programs for all substances of human origin. A group of experts (see Acknowledgments) developed definitions for proven, probable, possible, unlikely, excluded, intervened upon without documented transmission, and positive assay without apparent disease transmission events that should be used, as a starting point, to standardize nomenclature and facilitate global tracking and study of such infectious disease transmissions.